Competence and Service

  • An average annual performance of 20 EMA/FDA trials with approximately 150 subjects, both HIV and HCV from phase Ib to phase IIIb, also including pharmacokinetic studies, long term observations and roll-over studies
  • Participation in the development of all mayor ART since 1997 and therapeutic HIV-vaccine trials since 2009
  • Participation in protease/polymerase inhibitor studies for enhanced HCV-treatment since 2008
  • Experienced staff in conducting clinical trials, regularly trained in Good Clinical  Practice, competent in HIV/HCV and associated fields of expertise
  • One full time and one part time investigator, three study-coordinators, a finance and legal officer and relief nurses led by the principal investigator
  • Teaching on GCP courses

Pre-Study

  • Regular attendance of investigator meetings, conferences and trainings
  • Skilled in submitting trials to IRB/EC
  • Thorough pre-screening due to the access to the original subject data provided by the EPIMED associated private practices
  • Constant technical upgrading of data and information technologies for subject privacy and data confidentiality by the company data protection officer
  • Diligent and committed informed consent process and qualified subject handling

Study

  • Highest level of performance in the implementation of every study protocol detail
  • 24 hour surveillance of the patients in pharmacokinetic studies at the outpatient unit at the Immunologische Tagesklinik of the Vivantes Auguste-Viktoria-Klinikum
  • Experienced handling of electronic documentation (eCRF) e.g. InForm, Oracle
  • Long-term experience in the processing and shipment of samples and medication according to protocol requirements
  • Comprehensive support of the monitoring process

Post-Study

  • Accurate post-processing  of trials and secure archiving
  • Permanent qualitiy assurance through six sponsor audits and one helath authoirity inspection over 8 years
  • Numerous publication co-authorships

Last change: 03/07/2016